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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

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ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM Back to Search Results
Model Number 26GA (1.9F) X 30CM
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  malfunction  
Manufacturer Narrative
The sample is indicated as available for evaluation. A follow-up report will be submitted once the sample has been received and reviewed.
 
Event Description
¿i had 2 lcath 1. 9fr catheters break on me last night. Lot number 11347875 and lot 11332530. It was when i went to remove the guidewire. I had pre-flushed them but they accordioned and broke at the purple part. It was extremely frustrating because i had to place a 1. 2fr in a (b)(6) kg baby after placing 2 of the 1. 9. ".
 
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Brand NameL-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
Type of DeviceL-CATH PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key11634934
MDR Text Key246236402
Report Number1625425-2021-00901
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number26GA (1.9F) X 30CM
Device Catalogue Number384539
Device Lot Number11332530
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/08/2021 Patient Sequence Number: 1
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